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Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children.pdf

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Probiotics for the prevention of Clostridium difficile- associated diarrhea in adults and children (Review) Goldenberg JZ, Ma SSY, Saxton JD, Martzen MR, Vandvik PO, Thorlund K, Guyatt GH, Johnston BC This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2013, Issue 5 http://www.thecochranelibrary.com Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (Review) Copyright © 2
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  Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (Review) Goldenberg JZ, Ma SSY, Saxton JD, Martzen MR, Vandvik PO, Thorlund K, Guyatt GH, Johnston BC Thisisareprintof aCochrane review, preparedandmaintained byThe Cochrane Collaboration andpublishedin  TheCochrane Library  2013, Issue 5http://www.thecochranelibrary.com Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (Review)Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.  T A B L E O F C O N T E N T S 1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .7BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1718DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 C. difficile associated diarrhea, Outcome 1 Incidence CDAD: complete case. . . . . 100 Analysis 1.2. Comparison 1 C. difficile associated diarrhea, Outcome 2 Incidence CDAD: complete case - fixed effects. 102 Analysis 1.3. Comparison 1 C. difficile associated diarrhea, Outcome 3 Incidence CDAD Sensitivity (1.5:1). . . . 103 Analysis 1.4. Comparison 1 C. difficile associated diarrhea, Outcome 4 Incidence CDAD Sensitivity (2:1). . . . . 104 Analysis 1.5. Comparison 1 C. difficile associated diarrhea, Outcome 5 Incidence CDAD Sensitivity (3:1). . . . . 106 Analysis 1.6. Comparison 1 C. difficile associated diarrhea, Outcome 6 Incidence CDAD Sensitivity (5:1). . . . . 107 Analysis 1.7. Comparison 1 C. difficile associated diarrhea, Outcome 7 Incidence CDAD: Subgroup: Inpatient versusoutpatient populations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Analysis 1.8. Comparison 1 C. difficile associated diarrhea, Outcome 8 Incidence CDAD: Subgroup: Species: all. . 110 Analysis 1.9. Comparison 1 C. difficile associated diarrhea, Outcome 9 Incidence CDAD: Subgroup: Species: LGG versusSB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Analysis 1.10. Comparison 1 C. difficile associated diarrhea, Outcome 10 Incidence CDAD: Subgroup: Species: LGGversus LA + LC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 Analysis 1.11. Comparison 1 C. difficile associated diarrhea, Outcome 11 Incidence CDAD: Subgroup: Risk of Bias. 115 Analysis 1.12. Comparison 1 C. difficile associated diarrhea, Outcome 12 Incidence CDAD: Subgroup: Adult versuschild. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Analysis 2.1. Comparison 2 Adverse events, Outcome 1 Adverse Events: complete case. . . . . . . . . . . 119 Analysis 2.2. Comparison 2 Adverse events, Outcome 2 Adverse Events: Subgroup: Risk of Bias. . . . . . . . 120 Analysis 2.3. Comparison 2 Adverse events, Outcome 3 AE Sensitivity 1.5:1. . . . . . . . . . . . . . . 122 Analysis 2.4. Comparison 2 Adverse events, Outcome 4 AE Sensitivity 2:1. . . . . . . . . . . . . . . . 123 Analysis 2.5. Comparison 2 Adverse events, Outcome 5 AE Sensitivity 3:1. . . . . . . . . . . . . . . . 125 Analysis 2.6. Comparison 2 Adverse events, Outcome 6 AE Sensitivity 5:1. . . . . . . . . . . . . . . . 126 Analysis 3.1. Comparison 3 Incidence of Clostridium difficile infection, Outcome 1 Incidence of infection: completecase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Analysis 3.2. Comparison 3 Incidence of Clostridium difficile infection, Outcome 2 Incidence of infection: Subgroup: Risk of Bias. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Analysis 4.1. Comparison 4 Length of hospital stay, Outcome 1 Length of Hospital Stay: complete case. . . . . . 130 Analysis 5.1. Comparison 5 Antibiotic associated diarrhea, Outcome 1 Incidence AAD: complete case. . . . . . 131 Analysis 5.2. Comparison 5 Antibiotic associated diarrhea, Outcome 2 Incidence AAD: Subgroup: Risk of Bias. . . 132 Analysis 5.3. Comparison 5 Antibiotic associated diarrhea, Outcome 3 Incidence AAD: sensitivity (1.5:1). . . . . 134 Analysis 5.4. Comparison 5 Antibiotic associated diarrhea, Outcome 4 Incidence AAD: sensitivity (2:1). . . . . . 135 iProbiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (Review)Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.   Analysis 5.5. Comparison 5 Antibiotic associated diarrhea, Outcome 5 Incidence AAD: sensitivity (3:1). . . . . . 137 Analysis 5.6. Comparison 5 Antibiotic associated diarrhea, Outcome 6 Incidence AAD: sensitivity (5:1). . . . . . 138 Analysis 5.7. Comparison 5 Antibiotic associated diarrhea, Outcome 7 Patient population. . . . . . . . . . 140 Analysis 5.8. Comparison 5 Antibiotic associated diarrhea, Outcome 8 Species: all. . . . . . . . . . . . . 142 Analysis 5.9. Comparison 5 Antibiotic associated diarrhea, Outcome 9 Species: LGG versus SB. . . . . . . . 145 Analysis 5.10. Comparison 5 Antibiotic associated diarrhea, Outcome 10 Species: LGG versus LA + LC. . . . . 146 Analysis 5.11. Comparison 5 Antibiotic associated diarrhea, Outcome 11 Adult versus child. . . . . . . . . . 147148 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .149INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiProbiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (Review)Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.  [Intervention Review] Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children  JoshuaZGoldenberg  1 ,Stephanie SYMa  2 ,Jane DSaxton 1 ,MarkRMartzen 3 ,Per OVandvik  4 ,Kristian Thorlund 5 , GordonHGuyatt 5 , Bradley C Johnston 6 , 71 Bastyr University, Seattle, USA.  2 Division of Plastic & Reconstructive Surgery, McMaster University, Hamilton, Canada.  3 BastyrUniversityResearchInstitute, Bastyr University,Kenmore,USA. 4 NorwegianKnowledgeCentrefortheHealthServices,Oslo,Norway. 5 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.  6 The Hospital for Sick ChildrenResearchInstitute, Toronto, Canada.  7 Institute of HealthPolicy,Management andEvaluation, University ofToronto, Toronto, Canada Contact address: Bradley C Johnston, bradley.johnston@sickkids.ca . bjohnst@mcmaster.ca . Editorial group:  Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Group. Publication status and date:  New, published in Issue 5, 2013. Review content assessed as up-to-date:  21 February 2013. Citation:  Goldenberg JZ, Ma SSY, Saxton JD, Martzen MR, Vandvik PO, Thorlund K, Guyatt GH, Johnston BC. Probiotics for theprevention of Clostridium difficile-associated diarrhea in adults and children.  Cochrane Database of Systematic Reviews   2013, Issue 5. Art. No.: CD006095. DOI: 10.1002/14651858.CD006095.pub3.Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. A B S T R A C T Background  Antibiotics are widely prescribed; however they can cause disturbances in gastrointestinal flora which may lead to reduced resistance topathogens such as  Clostridium difficile   ( C. difficile) . Probiotics are live organisms thought to balance the gastrointestinal flora. Objectives Theprimaryobjectivesweretoassesstheefficacyandsafetyofprobioticsforpreventing  Clostridiumdifficile  -associateddiarrhea(CDAD)or  C. difficile   infection in adults and children. Search methods OnFebruary21,2013 wesearchedPubMed(1966-2013), EMBASE(1966-2013), CochraneCentralRegisterofControlledTrials( The Cochrane Library   2013, Issue 1), CINAHL (1982-2013), AMED (1985-2013), and ISI Web of Science. Additionally, we conductedan extensive grey literature search including contact with industry representatives. Selection criteria  Randomized controlled (placebo, alternative prophylaxis, or no treatment control) trials investigating probiotics (any strain, any dose)for prevention of CDAD, or  C. difficile   infection were considered for inclusion. Data collection and analysis Two authors independently and in duplicate extracted data and assessed risk of bias using pre-constructed, and piloted, data extractionforms. Any disagreements were resolved by a third adjudicator. For articles published in abstract form only, further information wassoughtbycontacting principalauthors. Theprimaryoutcome wastheincidence ofCDAD. Secondaryoutcomesincludedtheincidenceof   C. difficile   infection, adverse events, antibiotic-associated diarrhea (AAD) and length of hospital stay. Dichotomous outcomes (e.g.incidence ofCDAD)werepooledusingarandom-effectsmodeltocalculatetherelativeriskandcorresponding 95%confidence interval(95% CI). Continuous outcomes (e.g. length of hospital) were pooled using a random-effects model to calculate the mean difference 1Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (Review)Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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